On November 2019 ADC Therapeutics SA, a clinical-stage oncology-focused biotechnology company pioneering the development of highly potent antibody drug conjugates (ADCs) for patients suffering from hematological malignancies and solid tumors, reported that two abstracts on ADCT-402 (loncastuximab tesirine) have been selected for an oral and poster presentation at the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held December 7-10, 2019, in Orlando, FL (Press release, ADC Therapeutics, NOV 6, 2019, View Source [SID1234596052]).
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Jay Feingold, MD, PhD, Senior Vice President, Chief Medical Officer and Head of Oncology Clinical Development at ADC Therapeutics, said, "We look forward to sharing updated interim efficacy data from our pivotal Phase 2 clinical trial of ADCT-402 in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which demonstrate its encouraging single-agent clinical activity and manageable toxicity in a difficult-to-treat patient population and support our plans to submit a Biologics License Application to the U.S. Food and Drug Administration in the second half of 2020. In addition, we are pleased to share information about our Phase 1 trial evaluating ADCT-402 plus durvalumab. These presentations at the ASH (Free ASH Whitepaper) Annual Meeting validate the potential of ADCT-402 to fill a significant unmet medical need for heavily pretreated patients with B-cell non-Hodgkin lymphomas, both as a single agent and in combination with approved therapies."
Oral Presentation
Title: Interim Futility Analysis of a Phase 2 Study of Loncastuximab Tesirine, a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Abstract Number: 757
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Novel Therapies in Relapsed/Refractory Disease
Date and Time: Monday, December 9, 2019; 2:45 p.m. ET
Location: Orange County Convention Center, W304ABCD
Presenter: Carmelo Carlo-Stella, MD, Humanitas Cancer Center, Humanitas University
Poster Presentation
Title: Safety and Anti-Tumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma
Abstract Number: 2807
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
Date and Time: Sunday, December 8, 2019; 6 – 8 p.m. ET
Location: Orange County Convention Center, Hall B
Presenter: Craig Moskowitz, MD, Sylvester Comprehensive Cancer Center, University of Miami Health System
For more information about the ASH (Free ASH Whitepaper) Annual Meeting, visit View Source
ADC Therapeutics to Host Event ADC Therapeutics will host an investor and analyst event beginning at 8 p.m. ET on Sunday, December 8, 2019. This event will not be webcast.
About ADCT-402
ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, ADCT-402 is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies. ADCT-402 is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (NCT03589469), a Phase 1b trial in combination with ibrutinib in patients with R/R DLBCL or mantle cell lymphoma (MCL) (NCT03684694) and a Phase 1b trial in combination with durvalumab in patients with R/R DLBCL, MCL or follicular lymphoma (NCT03685344). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of relapsed or refractory DLBCL and MCL.